Trials / Recruiting
RecruitingNCT07170800
A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets
A Multicenter, Open-label, Randomized, Active-controlled Clinical Study to Compare the Efficacy and Safety of Different Combination Regimens of JDB0131 Benzenesulfonate Tablets With Delamanid in Patients With Rifampin-resistant Tuberculosis (JD-RISE)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- WestVac Biopharma Co., Ltd. · Industry
- Sex
- All
- Age
- 14 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized, open-label, active-controlled clinical study designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of different doses of JDB0131 benzenesulfonate tablets compared with delamanid in combination with bedaquiline, linezolid, levofloxacin (moxifloxacin)/clofazimine, etc. in the treatment of patients with drug-resistant (including rifampicin-resistant) tuberculosis for 8 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JDB0131 100mg | Bedaquiline (B): For the first 2 weeks, 400 mg qd; then adjust to 200 mg tiw. JDB0131 (J): 100 mg bid. Linezolid (L): 600 mg qd. Levofloxacin (Lfx): According to body weight, patients ≤50 kg, 750 mg qd; patients \>50 kg, 1000 mg qd. Moxifloxacin (M): 400 mg qd. Clofazimine (C): 100 mg qd. |
| DRUG | JDB0131 200mg | Bedaquiline (B): For the first 2 weeks, 400 mg qd; then adjust to 200 mg tiw. JDB0131 (J): 200 mg bid. Linezolid (L): 600 mg qd. Levofloxacin (Lfx): According to body weight, patients ≤50 kg, 750 mg qd; patients \>50 kg, 1000 mg qd. Moxifloxacin (M): 400 mg qd. Clofazimine (C): 100 mg qd. |
| DRUG | Delamanid (D) | Bedaquiline (B): For the first 2 weeks, 400 mg qd; then adjust to 200 mg tiw. Delamanid (D): 100 mg bid. Linezolid (L): 600 mg qd. Levofloxacin (Lfx): According to body weight, patients ≤50 kg, 750 mg qd; patients \>50 kg, 1000 mg qd. Moxifloxacin (M): 400 mg qd. Clofazimine (C): 100 mg qd. |
Timeline
- Start date
- 2025-09-19
- Primary completion
- 2026-02-28
- Completion
- 2026-09-04
- First posted
- 2025-09-12
- Last updated
- 2026-01-30
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07170800. Inclusion in this directory is not an endorsement.